{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T10:32:45Z","timestamp":1790677965883,"version":"4.1.0"},"reference-count":47,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2020,1,7]],"date-time":"2020-01-07T00:00:00Z","timestamp":1578355200000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000015","name":"Canadian Cancer Society Research Institute","doi-asserted-by":"publisher","award":["319371"],"award-info":[{"award-number":["319371"]}],"id":[{"id":"10.13039\/501100000015","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Concerns unique to women with breast cancer can include impact of cancer on body image, sexual well-being and changes in breast appearance and sensation. These important issues are not captured by the existing generic preference-based measures (PBMs) and no breast cancer-specific PBM currently exists. This Phase 1 protocol describes a mixed-methods study to develop and validate the descriptive health state classification system for a breast cancer-specific PBM, called the BREAST-Q Utility module.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>A heterogeneous sample of women aged 18 years and older diagnosed with breast cancer who are undergoing or have had treatment for breast cancer will be invited to participate in qualitative interviews. Participants will be asked to describe impact of their diagnosis and treatment(s) on their health-related quality of life (HRQOL). Interviews will be audio recorded, transcribed verbatim and coded using a line-by-line approach. At the end of each interview, based on each participant\u2019s cancer treatment history, patients will complete the mastectomy, breast-conserving therapy or reconstruction module of BREAST-Q, with modified 5-point Likert scale to measure importance of the BREAST-Q concepts. Both sources of data will be analysed to identify the most important HRQOL concerns.<\/jats:p><jats:p>A conceptual framework and item pool will be developed from the qualitative dataset. Preliminary version of the BREAST-Q Utility module will be created and refined at an in-person meeting of multidisciplinary experts. Content validity of the Utility module will be examined (cognitive debriefing, expert feedback). Psychometric properties of Utility module will be evaluated in a large sample of women with breast cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>The study has been approved by Hamilton Integrated Research Ethics Board, Canada. Results of this study will be presented at international conferences and published in peer-reviewed journals.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2019-034451","type":"journal-article","created":{"date-parts":[[2020,1,8]],"date-time":"2020-01-08T08:55:35Z","timestamp":1578473735000},"page":"e034451","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["International phase 1 study protocol to develop a health state classification system for a preference-based measure for women with breast cancer: the BREAST-Q Utility module"],"prefix":"10.1136","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1911-0395","authenticated-orcid":false,"given":"Manraj","family":"Kaur","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea L","family":"Pusic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan J","family":"Cano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Xie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Bordeleau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toni","family":"Zhong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4720-0096","authenticated-orcid":false,"given":"Anne","family":"Klassen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2020,1,7]]},"reference":[{"key":"2020050713292690000_10.1.e034451.1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djq495"},{"key":"2020050713292690000_10.1.e034451.2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djn175"},{"key":"2020050713292690000_10.1.e034451.3","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-11-0650"},{"key":"2020050713292690000_10.1.e034451.4","doi-asserted-by":"crossref","unstructured":"Servick K . Breast cancer: a world of differences. American association for the advancement of science 2014.","DOI":"10.1126\/science.343.6178.1452"},{"key":"2020050713292690000_10.1.e034451.5","unstructured":"Breast Cancer \u2013 Statistics. . (2019, August 22). Retrieved October 18, 2019, from. Available: https:\/\/www.cancer.net\/cancer-types\/breast-cancer\/statistics"},{"key":"2020050713292690000_10.1.e034451.6","doi-asserted-by":"crossref","unstructured":"Gold MR , Siegel JE , Russell LB . Cost-Effectiveness in health and medicine. Oxford university press, 1996.","DOI":"10.1093\/oso\/9780195108248.001.0001"},{"key":"2020050713292690000_10.1.e034451.7","unstructured":"Musgrove P , Fox-Rushby J . Cost-Effectiveness analysis for priority setting. disease control priorities in developing countries. 2006;2."},{"key":"2020050713292690000_10.1.e034451.8"},{"key":"2020050713292690000_10.1.e034451.9","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1996.03540140060028"},{"key":"2020050713292690000_10.1.e034451.10","doi-asserted-by":"crossref","unstructured":"Pinto-Prades JL , Attema A , S\u00e1nchez-Mart\u00ednez FI . Measuring health utility in economics. Oxford research encyclopedia of economics and finance 2019.","DOI":"10.1093\/acrefore\/9780190625979.013.85"},{"key":"2020050713292690000_10.1.e034451.11","unstructured":"PBAC . Pharmaceutical benefits Advisory Committee). guidelines for preparing submissions to the pharmaceutical benefits Advisory Committee. Australia: Australian Government Department of Health, 2013."},{"key":"2020050713292690000_10.1.e034451.12","unstructured":"CADTH . Canadian agency for drugs and technologies in health). guidelines for the economic evaluation of health technologies. Canada: CADTH, 2006."},{"key":"2020050713292690000_10.1.e034451.13","unstructured":"NICE (National Institute of Health and Care Excellence) . Guide to the methods of technology appraisal. London: NICE, 2013."},{"key":"2020050713292690000_10.1.e034451.14","unstructured":"SMC (Scottish Medicines Consortium) . Guidance to manufacturers for completion of new product assessment form (NPAF). Scotland: NHS Scotland, 2016."},{"key":"2020050713292690000_10.1.e034451.15","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1007\/s40273-017-0544-y","article-title":"International regulations and recommendations for utility data for health technology assessment","volume":"35","author":"Rowen","year":"2017","journal-title":"Pharmacoeconomics"},{"key":"2020050713292690000_10.1.e034451.16","unstructured":"Kaur M . Health state utility values in breast cancer: a systematic review of literature 2019."},{"key":"2020050713292690000_10.1.e034451.17","doi-asserted-by":"crossref","unstructured":"Brazier J , Ratcliffe J , Saloman J , et al . Measuring and valuing health benefits for economic evaluation. OXFORD university press, 2017.","DOI":"10.1093\/med\/9780198725923.001.0001"},{"key":"2020050713292690000_10.1.e034451.18","unstructured":"U.S Department of Health and Human Services Food and Drug Administration . Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. Available: http:\/\/www. fda. gov\/ downloads\/ Drugs\/ Guidances\/UCM193282. pdf"},{"key":"2020050713292690000_10.1.e034451.19","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1098-240X(199704)20:2<169::AID-NUR9>3.0.CO;2-I"},{"key":"2020050713292690000_10.1.e034451.20","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1177\/160940690400300101","article-title":"The analytic challenge in interpretive description","volume":"3","author":"Thorne","year":"2004","journal-title":"Int J Qual Methods"},{"key":"2020050713292690000_10.1.e034451.21","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0b013e3181aee807"},{"key":"2020050713292690000_10.1.e034451.22","unstructured":"Patton MQ . Qualitative research and evaluation methods. 3rd ed. Thousand Oaks, CA: Sage, 2002."},{"key":"2020050713292690000_10.1.e034451.23","unstructured":"Opdenakker R . Advantages and disadvantages of four interview techniques in qualitative research. In: Forum qualitative Sozialforschung\/Forum. 7th vol. Qualitative Social Research, 2006: 4."},{"key":"2020050713292690000_10.1.e034451.24","unstructured":"Crabtree BF , Miller WL , eds. Doing qualitative research. Sage Publications, 1999."},{"key":"2020050713292690000_10.1.e034451.25","doi-asserted-by":"crossref","first-page":"38","DOI":"10.4135\/9781849208574.n4","article-title":"Thematic coding and categorizing","volume":"703","author":"Gibbs","year":"2007","journal-title":"Analyzing qualitative data"},{"key":"2020050713292690000_10.1.e034451.26","doi-asserted-by":"crossref","unstructured":"Charmaz K , Belgrave LL . Grounded theory. The Blackwell encyclopedia of sociology 2007.","DOI":"10.1002\/9781405165518.wbeosg070"},{"key":"2020050713292690000_10.1.e034451.27","doi-asserted-by":"publisher","DOI":"10.1023\/A:1023254226592"},{"key":"2020050713292690000_10.1.e034451.28","unstructured":"Van Someren MW , Barnard YF , Sandberg JA . The think-aloud method: a practical approach to modeling cognitive. London: Academic Press, 1994."},{"key":"2020050713292690000_10.1.e034451.29","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1007\/s11136-018-1829-0","article-title":"COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study","volume":"27","author":"Terwee","year":"2018","journal-title":"Qual Life Res"},{"key":"2020050713292690000_10.1.e034451.30","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.013"},{"key":"2020050713292690000_10.1.e034451.31","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.014"},{"key":"2020050713292690000_10.1.e034451.32","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2020050713292690000_10.1.e034451.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2006.03.012"},{"key":"2020050713292690000_10.1.e034451.34","doi-asserted-by":"publisher","DOI":"10.3109\/07853890109002087"},{"key":"2020050713292690000_10.1.e034451.35","doi-asserted-by":"publisher","DOI":"10.1016\/0168-8510(90)90421-9"},{"key":"2020050713292690000_10.1.e034451.36","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-011-9903-x"},{"key":"2020050713292690000_10.1.e034451.37","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/85.5.365"},{"key":"2020050713292690000_10.1.e034451.38","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1016\/j.jval.2011.01.004","article-title":"Deriving a preference-based measure for cancer using the EORTC QLQ-C30","volume":"14","author":"Rowen","year":"2011","journal-title":"Value in Health"},{"key":"2020050713292690000_10.1.e034451.39","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1097\/00005650-199603000-00003","article-title":"A 12-Item short-form health survey: construction of scales and preliminary tests of reliability and validity","volume":"1","author":"Ware Jr","year":"1996","journal-title":"Medical care"},{"key":"2020050713292690000_10.1.e034451.40","doi-asserted-by":"publisher","DOI":"10.1097\/01.mlr.0000135827.18610.0d"},{"key":"2020050713292690000_10.1.e034451.41","doi-asserted-by":"publisher","DOI":"10.1037\/h0026256"},{"key":"2020050713292690000_10.1.e034451.42","doi-asserted-by":"publisher","DOI":"10.1053\/ejso.1999.0734"},{"key":"2020050713292690000_10.1.e034451.43","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1007\/s00520-016-3417-6","article-title":"Quality of life (QOL) and symptom burden (SB) in patients with breast cancer","volume":"25","author":"Hamer","year":"2017","journal-title":"Support Care Cancer"},{"key":"2020050713292690000_10.1.e034451.44","doi-asserted-by":"crossref","first-page":"2939","DOI":"10.1007\/s11136-015-1034-3","article-title":"Quality of life and metastatic breast cancer: the role of body image, disease site and time since diagnosis","volume":"24","author":"McClelland","year":"2015","journal-title":"Qual Life Res"},{"key":"2020050713292690000_10.1.e034451.45","doi-asserted-by":"crossref","first-page":"1198","DOI":"10.1097\/SLA.0000000000000908","article-title":"Patient-Reported quality of life and satisfaction with cosmetic outcomes after breast conservation and mastectomy with and without reconstruction: results of a survey of breast cancer survivors","volume":"261","author":"Jagsi","year":"2015","journal-title":"Ann Surg"},{"key":"2020050713292690000_10.1.e034451.46","unstructured":"Nunnally JC . Psychometric theory 3E. TATA McGraw-Hill education 1994."},{"key":"2020050713292690000_10.1.e034451.47","doi-asserted-by":"publisher","DOI":"10.1037\/0033-2909.112.1.155"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-034451","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T21:17:25Z","timestamp":1722287845000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-034451"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1]]},"references-count":47,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2020,1,10]]},"published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1136\/bmjopen-2019-034451"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-034451","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1]]}}}